Biologics

6 Goals in CBER Strategic Plan

The Center for Biologics Evaluation and Research interim strategic plan for 2017-2019 includes five overarching program goals and a sixth cross-cutting goal. Center director Peter Marks identifies the goals as:

increase the nation’s preparedness to address threats as a result of terrorism, pandemic influenza, and emerging infectious diseases;
improve global public health through international collaboration including research and information sharing;
use advances in science and technology to facilitate development of safe and effective biological products;
ensure the safety of biological products;
advance regulatory science and research; and
manage for organizational excellence and accountability.

“We view this strategic plan as a living document that will allow is to modify our direction and approach as new regulatory challenges, obligations, and opportunities to serve the public’s health emerge,” Marks writes. The plan extends the CBER 2012-2016 strategic plan for two years, to carry the Center through establishment of new HHS and FDA strategic plans in 2018. The document contains objectives and strategies for each of the six goals.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome